1. Field of the Invention
The present invention relates to a patient support device, and more particularly, to a patient support device which provides improved full-body comfort to alert patients immobilized for one or more hours while undergoing imaging or interventional procedures.
2. Description of the Related Art
An increasing demand for diagnostic and interventional services such as femoral catheterization and coronary angiography, coupled with an increase in the complexity of the procedures, has resulted in a turbulent environment.
In these procedures a conscious patient is voluntarily immobilized on a temporary patient support, usually a 1-inch thick vinyl-covered foam pad, for one or more hours while undergoing diagnostic scanning or interventional procedures. During these procedures cardiologists and/or radiologists focus on the patient""s image/x-ray and the physicians focus on the procedure at hand. In the patient, lying still, anxious and alert, even a slight positional discomfort could, over a short time, develop into pain. The care/assessment and evaluation as well as the treatment of the patient is delegated to the nurse, who currently has limited resources for improving patient comfort.
The present inventor considered that if a baseline of patient comfort/satisfaction could be assured prior to the onset of any diagnostic or interventional procedure, the nurse could readily assess and treat the patient according to their actual physiologic symptoms (e.g., ischemic chest pain) instead of possible positional pain. Although the present inventor has felt a need for improving patient comfort prior to and during such procedures, there is no economical device or method for assuring patient full-body comfort.
The need for such a device or method increases with the increasing prevalence of procedures in which a conscious patient is required to lie immobile for one or more hours. For example, diagnostic and/or imaging procedures are normally performed outside the operating room, in a suite containing the scanning machine (CT, MRI, x-ray, etc.) and is dedicated to scanning procedures. During scanning, the patient is supported and moved about (translated or transferred) on a temporary support. Translation permits the patient to be moved into the scanning field of the scanning apparatus. Due to physical obstructions inherent in the bulky architecture of the scanning apparatus, particularly with MRI and CAT scans, the patient support is designed to be as narrow as possible, usually about 18 inches in width. The support is usually not wide enough to support the arms, and is narrowed in the area of the head.
The development of miniaturized surgical instruments and probes has resulted in an increase in the popularity of non-invasive surgery. Non-invasive surgery is usually performed using the above-mentioned imaging equipment as the eyes of the physician. The patient support is thus designed to be as narrow as possible to provide access not only to the surgical team, but also to the imaging equipment.
For example, carotid stenting is normally performed in the angiography room of the cath lab or x-ray department, and requires a conscious patient to remain immobile in a supine position for two hours or longer. A catheter is inserted into the patient""s femoral artery through a small incision in the right or left groin area. The catheter is selectively positioned up the aorta to the neck region where the carotid artery is blocked. Every few moments contrast is injected through the catheter. Using X-ray equipment (fluoroscopy), the patient""s blood vessels are continuously digitally imaged and monitored on overhead monitors, providing exact views by which the physician must guide or direct the catheter to reach the problem area.
Next, the physician inserts a second, more slender catheter inside the first one, with the stent over its tiny inflatable balloon stored securely inside crimped firmly to the catheter""s end. The patientxe2x80x94already immobile for almost one hourxe2x80x94is then asked to lie perfectly still and to not even swallow for the next few minutes. The stent is positioned, the balloon inflated, and stent stretched open to form a tiny wire cage, supporting the lumen or walls of the vessel. During this procedure the blood flow to the brain is constantly monitored. The angiography X-ray unit is repositioned around the patient, taking digital (moving) images from different angles. To this point, the procedure has taken two hours, during which the patient has remained awake and largely motionless. Any discomfort experienced by the patient during this period grows and intensifies over time.
As another example, percutaneous translumenal coronary angioplasty (PTCA) involves the percutaneous introduction of an inflatable balloon tipped catheter assembly into the femoral artery and its advancement through the arterial system to, e.g., an atherosclerotic coronary lesion. The balloon is then inflated to dilate the constricted vessel followed by stent placement in most cases.
Yet another non-surgical technique, intra-aortic balloon pump (IABP) counterpulsation, provides circulatory assistance to a patient experiencing cardiogenic shock. Using a needle, a guide wire and a dilator sheath assembly, an elongated catheter-mounted balloon pump is inserted percutaneously through an introducer sheath into a femoral artery, and the assembly travels through the abdominal aorta towards the heart and is positioned into the descending thoracic aorta.
For procedures such as those discussed above, catheterization of the femoral artery (and more recently the radial or wrist artery) is performed in a catheterization lab separate from the operating room where the patient is conscious, and not under general anesthesia such as is generally the case in the surgical suite or operating room.
For both scanning and catheterization, the patient support is considered to be only a temporary support. The patient rests on a one inch thick, vinyl covered foam pad. Apparently, a thin foam pad is believed to increase the stability (decrease roll) of the patient during imaging, and is erroneously believed to give adequate support and comfort to the patient.
However, from the perspective of the patient, such a thin and planar foam pad does not sufficiently conform to the contours of the body and thus fails to provide sufficient support. The patient is asked to remain perfectly motionless on this thin and narrow pad for one or two hours, during which he is awake and able to verbalize any concerns. Patients commonly complain of positional discomfort including back, hip, shoulder and neck pain, often requiring administration of narcotics for pain control. This can be associated with additional risk to the patient and may lengthen the post procedure phase of their care (as well as increase the cost to both the patient and hospital). Any undesirable vovement may cause the procedure to lengthen due to poor imaging quality combined with the need to repeat images. This repetition is costly and time consuming, and causes increased risk to patient, staff and physician.
Further, since the narrow support does not provide for patient arm support, the hands of the patient are simply tucked under the hips to secure them by their sides. This awkward positioning of the arms and hands is one of the primary causes for the patient""s discomfort and pain. Any minor discomfort, left unaddressed for as little as five or ten minutes, tends to intensify and develop into severe pain. Patient movement in response to the pain can be dangerous to the patient during a procedure as discussed above.
As discussed above, it is often the responsibility of the nurse to monitor and alleviate patient discomfort. This must be done without interfering with the imaging or interventional procedure at hand.
With the foregoing in mind, the present inventor investigated the presently available devices for supporting patients, and has found none which are simple in design, capable of use in conjunction with existing patient supports (gurneys, tables) and able to comfortably and safely support the full bodies of patients of varying body shapes and sizes.
A search of patent literature has revealed U.S. Pat. No. 5,742,963 entitled xe2x80x9cPatient support apparatusxe2x80x9d and teaching a patient support apparatus which includes a firm body support portion constructed of foam, with the foam having a first side for placement on a bed or gurney, and the second side upon which the body of the patient would be laid. The foam apparatus would include a principal upper torso support portion for supporting a patient generally from the top of the patient""s head to the lower buttock region of the patient; first and second leg portions which are attachable to a lower edge of the principal body support portion for supporting the legs of the patient, and attachable arm portions secured to the side edges of the upper body support portion for accommodating the arms of the patient. The upper sides of the principal body portion, leg portions and arm portions would further include contoured regions which would reflect the general shape of the patient as the patient is laid on the patient""s back on the apparatus, and would provide a soft yet firm support for the patient along the entire body region of the patient during transport. However, as the foam support is not adjustable, this xe2x80x9cone size fits allxe2x80x9d approach does not always provide satisfactory results.
U.S. Pat. No. 5,054,142 entitled xe2x80x9cContoured body cushionxe2x80x9d teaches a portable multi-component contoured body cushion for supporting at least portions of a body includes a head member configured and dimensioned for supporting the head portion, a chest member configured and dimensioned for supporting the chest portion, and an abdomen member configured and dimensioned for supporting the abdomen. If desired, an ankle bolster configured and dimensioned for supporting the lower leg and ankle portions is also provided. The chest member is formed of a plurality of preformed sheets of uniform thickness configured so as to provide recesses to accommodate the breasts and abdomen of the body and to provide supports at least for the sternum and collar portions. The abdomen member is formed of a plurality of preformed sheets of uniform thickness positioned one atop the other. This abdomen member is also configured so as to provide support for the pelvic region so as to generally straighten the lumbar spinal curve. Since the members are pre-formed, they best support a xe2x80x9cstandardxe2x80x9d figure.
U.S. Pat. No. 5,224,226 entitled xe2x80x9cBody support structurexe2x80x9d teaches a body support structure in the form of a mattress for supporting a person lying thereon. It comprises a body of resilient, compressible material, having a surface layer of resilient soft material. The body includes a head end edge and a foot end edge at its opposite end; two substantially parallel straight elongated side edges; a bottom face extending between the two side edges of the body; an upper face opposed to and spaced from the bottom face between the two side edges of the body; two spaced apart elongated ridges, one of the ridges extending along each side edge; a channel provided in the upper face extending between the two ridges, the channel joining smoothly to the two ridges on either side; a central raised part located in the channel between but distanced away from the opposite end edges and being positioned to support the lumbar region of a person lying in the channel and side parts provided on the ridges adjacent the central raised part. Again, this device is not adjustable in a simple manner to xe2x80x9cdial inxe2x80x9d optimal comfort of the patient.
Finally, U.S. Pat. No. 4,907,306 entitled xe2x80x9cSupine support device and method for treatment and prevention of malocclusion of the teethxe2x80x9d teaches a wedge-shaped pillow having recessed areas for a user""s torso and head to promote supine sleeping as a beneficial deterrent to orthodontic problems and to generally promote sleeping comfort. Detachable foam cushions may be provided in the lumbar and cervical regions. Removal and replacement of such foam cushions is inconvenient and time consuming, and worth-while only if the device is intended for use over a period of weeks or months. It would be inconvenient to adjust such a device to provide optimal comfort to single-use patients.
Not only are quality images and favorable therapeutic outcomes important, but also patient satisfaction is fundamental in the era of managed care. The patient must be satisfied with all aspects of the care he received. It is not enough that the patient xe2x80x9cenduredxe2x80x9d a hospital stayxe2x80x94he must be left with a feeling of satisfaction. In addition procedural time will decrease if patient comfort, support and safe immobility is assured. The pain associated with long periods of conscious immobilityxe2x80x94often during stressful proceduresxe2x80x94must be mitigated.
Thus, there is a significant need for improvement in comfort when supporting a patient immobilized for even a brief time during imaging or interventional procedures. Obviously, from the perspective of the hospital it would be preferred if such improvement could be achieved without great expense, and with measurable improvement in patient satisfaction.
Further, since the support on which the patient rests is normally radiolucent, that is, transparent to the scanning device, so that the support does not compromise the utility of the scanned image, any modification to the temporary patient support must be fully radiolucent.
Further yet, given the large number of patients visiting an imaging or catheterization lab, expediency dictates that a patient support have a simple design, be intuitively easy to operate, and be carefree in servicing, maintenance and disinfection requirements. The greater the range of adjustment, the greater the risk of errors and problems.
The present inventor extensively investigated the positive and negative design features of patient supports in wide-spread use. The inventor particularly considered the need to alleviate the most common complaints of patients, the requirement to maneuver the patient support around and into imaging equipment, the reluctance of hospitals to buy completely new equipment, the need for the patient support to be fully radiolucent, and the need for the patient support to be simple in design and operation, so that patient satisfaction is easily and readily achieved.
After extensive experimentation the inventor discovered a simple device which:
can be used in conjunction with the existing patient supports in a xe2x80x9cretrofitxe2x80x9d manner,
comfortably supports the body and prevents the major types of patient discomfort,
is adjustable to the preferences of the individual patient,
does not widen the patient support device and does not involve projections which may interfere with patient translation,
allows for patient head restraint as indicated for cerebrovascular studies and interventions, allows for arm restraints for patient comfort and safe immobility,
is fully radiolucent,
can remain in place when not actively in use,
is extremely simple in design and operation, and
is easily disinfected.
More specifically, the inventor discovered that there are four specific areas of the conventional patient support which require improvement, and developed a simple device which addresses these areas.
The inventor determined that the uniformly flat one-inch foam pad upon which the body is resting for one to two hours is deficient in providing support in at three primary regions of the body necessary for the comfort of the patient, and determined that a significant improvement can be made by providing additional support means for selectively supporting one or more of the neck (cervical support), lower back (lumbar support), and knees (patellar support). In this regard, the inventive device comprises a patient support, preferably with integral foam pad, which can be simply laid over the top of a conventional foam pad, and/or which can be used as a replacement of the existing patient support pad, and which preferably comprises three inflatable bladders, one each for the cervical, lumbar and patellar areas. One or more additional bladders may be provided for comfort or immobilization of the head.
Further, the inventor determined that the arms of the patient in supine position can be simply and comfortably supported laterally along the sides of the patient using a modified pair of slings, i.e., flexible, waterproof and easily disinfected material, preferably vinyl, extending respectively laterally outward from the left and right sides of the supplemental support device, in the manner of wings. After the patient is positioned on the patient support device with arms placed along his or her sides, one sling is simply folded over the top of the patient with the tips releasably attached to each other using, e.g., VELCRO means at the patient""s side. These slings are made of a radiolucent material, thus can be used in medical scanning without interference with the imaging process.
The foregoing has outlined rather broadly the more pertinent and important features of the present invention in order that the detailed description of the invention that follows may be better understood and so that the present contribution to the art can be more fully appreciated. Additional features of the invention will be described hereinafter, which form the subject of the claims of the invention. It should be appreciated by those skilled in the art that the conception and the specific embodiments disclosed may be readily utilized as a basis for modifying or designing other patient support devices for carrying out the same purposes of the present invention. It should also be realized by those skilled in the art that such equivalent structures do not depart from the spirit and scope of the invention as set forth in the appended claims.